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Product and process innovation in biopharmaceuticals: a new perspective on development

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Developing new products and processes is increasingly a focal point of competition and often requires the development and successful implementation of novel process technologies. The process development and production of a new biological entity are significantly more complex than those for small molecule drugs. Conventional new product development models in the literature on firm level innovation fail to explain the nature of development projects for biopharmaceuticals. This paper makes the case that a new perspective is required to understand the management of product and process development in biopharmaceuticals. An explanatory model is proposed for this purpose.

Document Type: Research Article


Affiliations: Institute for Manufacturing, University of Cambridge, UK , Email:

Publication date: January 1, 2006

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